FDA accepts aBLA for Avastin biosimilar, MYL 14020.-Mylan
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Biocon Biologics announced that Abevmy, a biosimilar of bevacizumab and developed with Viatris Inc.( ex Mylan) has received marketing authorisation from the European Commission following a positive recommendation by the CHMP of the European Medicines Agency.
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Abevmy, intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
Bio-Thera Solutions announced that the FDA has accepted its Biologics License Application (BLA) for BAT 1706 (bevacizumab biosimilar), a proposed biosimilar to Avastin.